83 FR 46166 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 177 (September 12, 2018)

Page Range		46166-46170
FR Document		2018-19742

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 83 Issue 177 (Wednesday, September 12, 2018)

[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Notices]
[Pages 46166-46170]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-19742]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1960]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; MedWatch: The Food
and Drug Administration Medical Products Reporting Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October
12, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0291 and
title ``MedWatch: The Food and Drug Administration Medical Products
Reporting Program.'' Also include the FDA docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

MedWatch: The FDA Medical Products Reporting Program

OMB Control Number 0910-0291--Revision

This information collection supports FDA's MedWatch safety
information and adverse event reporting program. Members of the public
use FDA's MedWatch system to report adverse events, product problems,
errors with the use of a human medical product, or when evidence of
therapeutic failure is suspected or identified in clinical use.

[[Page 46167]]

To ensure the marketing of safe and effective products, it is critical
that postmarketing adverse outcomes and product problems are reported
for all FDA-regulated human healthcare products, including drugs
(prescription and nonprescription), biologics, medical devices, dietary
supplements, and other special nutritional products (e.g. infant
formula and medical foods), and cosmetics. To facilitate reporting on
human medical products (except vaccines) during their postapproval and
marketed lifetimes, we have developed three forms (collectively known
as the MedWatch forms). Form FDA 3500 is intended to be used for
voluntary (i.e., not mandated by law or regulation) reporting by
healthcare professionals; Form FDA 3500A is used for mandatory
reporting (i.e., required by law or regulation); and Form FDA 3500B is
written in plain language and is intended to be used for voluntary
reporting (i.e., not mandated by law or regulation) by consumers (i.e.,
patients and their caregivers). Information collected by the forms is
used to assess and evaluate risks associated with FDA-regulated
products, enabling us to take appropriate action to reduce, mitigate,
or eliminate the public's exposure to the risk through regulatory and
public health interventions.

I. Background

A. Authorizing Statutes and Codified Regulations

The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
353b, 355, 360i, 360l, and 393) and the Public Health Service Act (42
U.S.C. 262) require FDA to collect mandatory adverse event reports from
regulated industry on medical products once they have been approved for
marketing, enabling the Agency to monitor the safety of drugs,
biologics, medical devices, and dietary supplements. Postmarket
reporting for medical foods, infant formula, cosmetics, and tobacco
products is done voluntarily.
Requirements regarding mandatory reporting of adverse events or
product problems are codified at parts 310, 314, 600, and 803 (21 CFR
parts 310, 314, 600, and 803), specifically Sec. Sec. 310.305, 314.80,
314.98, 600.80, 803.30, 803.50, 803.53, 803.56, and specified in
sections 503B, 760, and 761 of the FD&C Act (21 U.S.C. 353b, 379aa, and
379aa-1). Mandatory reporting of adverse reactions for human cells,
tissues, and cellular- and tissue-based products (HCT/Ps) is codified
at Sec. 1271.350 (21 CFR 1271.350).

B. Voluntary Reporting: Form FDA 3500

Voluntary reporting of adverse events is completed using Form FDA
3500 and may be used by healthcare professionals to submit all reports
not mandated by Federal law or regulation. Individual health
professionals are not required by law or regulation to submit reports
to the Agency or the manufacturer with the exception of Childhood
Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1). Reports for vaccines
are not submitted via MedWatch or MedWatch forms, but are submitted to
the Vaccines Adverse Event Reporting System, which is jointly
administered by FDA and the Centers for Disease Control and Prevention
and approved under OMB control number 0910-0308.
Hospitals are not required by Federal law or regulation to submit
reports associated with drug products, biological products, or special
nutritional products. However, hospitals and other user facilities are
required by Federal law to report medical device-related deaths and
serious injuries. Under Federal law and regulation, section 761(b)(1)
of the FD&C Act, a dietary supplement manufacturer, packer, or
distributor whose name appears on the label of a dietary supplement
marketed in the United States is required to submit to FDA any serious
adverse event report it receives regarding use of the dietary
supplement in the United States. However, FDA bears the burden to
gather and review evidence that a dietary supplement may be adulterated
under section 402 of the FD&C Act (21 U.S.C. 342) after that product is
marketed. Therefore, the Agency depends on the voluntary reporting by
health professionals, and especially by consumers, of suspected serious
adverse events and product quality problems associated with the use of
dietary supplements. All dietary supplement reports were previously
received by the Agency on paper versions of Form FDA 3500 (or Form FDA
3500B) (by mail or Fax). Currently, electronic reports may be sent to
the Agency via an online submission route called the Safety Reporting
Portal (https://www.safetyreporting.hhs.gov/ approved under OMB control
number 0910-0645). In that case, Form FDA 3500 (or Form FDA 3500B) is
not used.
Form FDA 3500 may be used to report to the Agency serious adverse
events, product problems, and product use errors and therapeutic
failures. The form is provided in both paper and electronic formats.
Reporters may mail or Fax paper forms to the Agency (a fillable PDF
version of the form is available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf) or reporters may
electronically submit a report via the MedWatch Online Voluntary
Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/).
Reporting is supported for drugs, non-vaccine biologicals, medical
devices, special nutritional products, cosmetics, and non-prescription
(over-the-counter (OTC)) human drug products marketed without an
approved application. The paper form may also be used to submit reports
about tobacco products and dietary supplements. Electronic reports for
tobacco products and dietary supplements may be submitted to the Agency
via an online submission route called the Safety Reporting Portal
(https://www.safetyreporting.hhs.gov/).

C. Mandatory Reporting: Form FDA 3500A

1. Drug and Biological Products
In sections 505(b) and (j), 503B, and 704 (21 U.S.C. 355(b) and
(j), 353B, and 374) of the FD&C Act, Congress has required that
important safety information relating to all human drug products be
made available to FDA so that it can take appropriate action to protect
the public health when necessary. Section 702 of the FD&C Act (21
U.S.C. 372) authorizes investigational powers to FDA for enforcement of
the FD&C Act. These statutory requirements regarding mandatory
reporting have been codified by FDA under parts 310 and 314 (drugs) and
600 (biological products). Mandatory reporting of adverse reactions for
HCT/Ps has been codified in Sec. 1271.350.
2. OTC Monograph Drug Products and Dietary Supplements
Section 760 of the FD&C Act provides for mandatory safety reporting
for non-prescription human drug products marketed without an approved
application as described in the Dietary Supplement and Nonprescription
Drug Consumer Protection Act (Pub. L. 109-462), which became law on
December 22, 2006. The law requires manufacturers, packers, and
distributors of nonprescription, OTC human drug products marketed
without an approved application (OTC monograph drug products) to submit
reports of adverse experiences from domestic sources. The law also
requires reports of serious adverse events to be submitted to FDA by
manufacturers of dietary supplements.

[[Page 46168]]

3. Postmarketing Safety Reports--Changes in Format Starting in June
2018
Current requirements specify that postmarketing adverse experience
reports must be submitted on paper on Form FDA 3500A (or the CIOMS)
(Council for International Organizations of Medical Sciences) I form
for serious, unexpected adverse experiences from a foreign source). For
the last several years the Agency has accepted electronic submissions
in lieu of the paper Form FDA 3500A on the condition they are submitted
in a manner that the Agency can process, review, and archive. On June
10, 2014, the Agency issued a final rule entitled ``Postmarketing
Safety Reports for Human Drug and Biological Products; Electronic
Submission Requirements'' (79 FR 33072) that requires electronic
submission of all mandatory postmarketing safety reports, including
individual case safety reports. Entities with mandatory reporting
obligations under parts 310 and 314 (drugs) and 600 (biological
products) and specified under section 760 of the FD&C Act must
implement this rule within 1 year of the issuance date (by June 10,
2015). For more information see: https://www.thefederalregister.org/fdsys/pkg/FR-2014-06-10/pdf/2014-13480.pdf.
4. Medical Device Products
Section 519 of the FD&C Act (21 U.S.C. 360i) requires manufacturers
and importers of devices intended for human use to establish and
maintain records, make reports, and provide information, as the
Secretary of Health and Human Services may, by regulation, reasonably
be required to provide assurance that such devices are not adulterated
or misbranded and to otherwise assure its safety and effectiveness. The
Safe Medical Devices Act of 1990 (Pub. L. 101-629), signed into law on
November 28, 1990, amends section 519 of the FD&C Act. The amendment
requires that user facilities such as hospitals, nursing homes,
ambulatory surgical facilities, and outpatient treatment facilities
report deaths related to medical devices to FDA and to the
manufacturer, if known. Serious illnesses and injuries are to be
reported to the manufacturer or to FDA if the manufacturer is not
known. These statutory requirements regarding mandatory reporting have
been codified by FDA under part 803. Part 803 mandates the use of Form
FDA 3500A for reporting to FDA on medical devices. The Medical Device
User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250),
signed into law October 26, 2002, amended section 519 of the FD&C Act.
The MDUFMA amendment (section 303) required FDA to revise the MedWatch
forms to facilitate the reporting of information relating to
reprocessed single-use devices, including the name of the reprocessor
and whether the device has been reused.

D. Voluntary Reporting by Consumers: Form FDA 3500B

Form FDA 3500B was developed for voluntary reporting by consumers
(i.e. patients and their caregivers) to submit reports not mandated by
Federal law or regulation. Individual patients or their caregivers are
not required by law or regulation to submit reports to the Agency or
the manufacturer.
FDA supports and encourages direct reporting to the Agency by
consumers and healthcare professionals of suspected serious adverse
outcomes and other product problems associated with human medical
products, (https://www.fda.gov/Safety/ReportaProblem/default.htm). FDA
has further encouraged voluntary reporting by requiring inclusion of
the MedWatch toll-free phone number or the MedWatch internet address on
all outpatient drug prescriptions dispensed, as mandated by section 17
of the Best Pharmaceuticals for Children Act (Pub. L. 107-109).
On March 25, 2008, section 906 of the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110-85) amended section 502(n) of the
FD&C Act (21 U.S.C. 352(n)) and mandated that published direct-to-
consumer advertisements for prescription drugs include the following
statement printed in conspicuous text (this includes vaccine products):
``You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit https://www.fda.gov/safety/medwatch, or call 1-
800-FDA-1088.''
Most private vendors of consumer medication information, the drug
product-specific instructions dispensed to consumers at outpatient
pharmacies, remind patients to report ``side effects'' to FDA and
provide contact information to permit reporting via the MedWatch
process. For this reporting FDA has created Form FDA 3500B, a modified
version of Form FDA 3500 tailored for consumers and written in plain
language (in conformance with the Plain Writing Act of 2010 (Pub. L.
111-274), https://www.thefederalregister.org/fdsys/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf).
Form FDA 3500B evolved from several iterations of draft versions,
with input from human factors experts, from other regulatory agencies,
and with extensive input from consumer advocacy groups and the general
public. Form FDA 3500B may be used to report to the Agency adverse
events, product problems, and product use errors. The form is provided
in both paper and electronic formats. Reporters may mail or Fax paper
forms to the Agency (a fillable PDF version of the form is available at
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf) or electronically submit a report via the MedWatch
Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/, approved under OMB control number 0910-0645).
Reporting is supported for drugs, non-vaccine biologicals, medical
devices, special nutritional products, cosmetics, and non-prescription
OTC human drug products marketed without an approved application. The
paper form may also be used to submit reports about tobacco products
and dietary supplements. Electronic reports for tobacco products and
dietary supplements may be submitted to the Agency via an online
submission route called the Safety Reporting Portal (https://www.safetyreporting.hhs.gov/, approved under OMB control number 0910-
0645).

II. Proposed Modification to Existing Forms FDA 3500, 3500A, and 3500B

A. General Changes

The proposed modifications to Form FDA 3500 and Form FDA 3500A
reflect changes that will bring the form into conformity, since the
previous OMB authorization in 2015, with current regulations, rules,
and guidances and fall into three categories: (1) Regulatory driven
revisions, (2) work improvements for the Center, and (3) report
processing improvements. We also welcome comments about translation of
Form FDA 3500B (consumer) into Spanish and other languages. Lastly,
formatting modifications are being proposed to several fields to
enhance the quality, utility, and clarity of the information.

B. Changes Proposed for Form FDA 3500

In section A, we are revising the heading of A3 to ``Current
Gender'' followed by check boxes next to the following options
``Female'', ``Male'', ``Intersex'', ``Transgender'', ``Prefer not to
disclose.''
In section B, we are revising B1 to ``Type of Report (check all
that apply)''. In section B2, we are removing ``(Devices)'' from the
last option. We are also splitting section B6 into two

[[Page 46169]]

questions: ``B6.a. Relevant Test (please included dates)'' and ``B6.b.
Relevant Laboratory Data (please included dates).''
In section C, we are adding question C2 ``Do you have a picture of
the product?''
In section D1, we are adding the question ``Does this report
involve cosmetics, dietary supplements or food?'' followed by a
checkbox for ``Yes.'' In section D4, we are adding the question ``Is
therapy still on-going?'' This question is important for
pharmacovigilance and the current form does not allow the reporter to
be specific. The current form does not allow the reporter to be
specific. It is proposed to combine boxes D6 and D7 and change the
title to ``Product Type'' (check all that apply).
In section E, we are adding question E9 ``Was this device serviced
by a third-party servicer?'' followed by a checkbox for ``Yes'' and a
checkbox for ``No.''

C. Changes Proposed for Form FDA 3500A

In section A, we are revising the heading of A3 to ``Current
Gender'' followed by check boxes next to the options ``Female'',
``Male'', ``Intersex'', ``Transgender'', ``Prefer not to disclose''.
In section B, we are revising the heading for BI to now read ``Type
of Report (check all that apply)''. In section B2, we are removing
``(Devices)'' from the last option. Section B6 is being split into two
questions: ``B6.a. Relevant Test (please include dates)'' and ``B6.b.
Relevant Laboratory Data (please include dates),''
In section C, we are combining boxes C6 and C7 and changing the
title to ``Product Type'' (check all that apply).
In section D, we are adding a new question ``Was this device
serviced by a third party?'' followed by a checkbox for ``Yes'' and a
checkbox for ``No.''
In section F, we are changing the revising the heading of F10 to
``Adverse Event Problem'' and splitting the ``Patient Code'' box into
two fields entitled ``Patient Outcome Code'' and ``Patient Severity
Code.'' We are also splitting the ``Device Code'' field into two fields
entitled ``Device Code'' and ``Component Code.''
In section G, question G1 will now include ``or Compounding
Outsourcing Facility'' after (and Manufacturing Site for Devices.)'' In
section G5, we are adding two new options entitled ``PreANDA'' and
``Compounded Product'' followed by a check box for ``Yes,'' and making
consistent changes within section G6 by replacing ``If IND,'' to ``Give
Protocol #.''
In section H1, we are adding a check box to indicate whether a
summary report is included followed by a field in which to indicate
``Number of Events Summarized'' and an open field in which to add text.
We are renaming section H6 to ``Adverse Event Problem'' and splitting
``Patient Code'' into two fields entitled ``Patient Outcome Code'' and
``Patient Severity Code.'' We are also splitting ``Device Code'' into
two fields entitled ``Device Code'' and ``Component Code.'' In section
H6, we are renaming the headings as follows: (1) ``Method'' to ``Type
of Investigation'' (2) ``Results'' to ``Investigation Findings'' and
(3) ``Conclusions'' to ``Investigation Conclusion.'' Finally, H10 is
becoming a field entitled ``Additional Manufacturer Narrative,'' and we
are adding field H11 entitled ``Corrected Data.''

D. Changes Proposed for Form FDA 3500B

On page 1, we are removing the text ``nutrition products, such as
vitamins and minerals, herbal remedies, infant formulas, and medical
foods.'' We are also going to number each of the questions included.
In section A, for the question ``Did any of the following happen?''
we are removing ``Devices)'' from the last option. We are also revising
the question ``List any relevant tests or laboratory data if you know
them. (Include dates)'' as two separate questions: ``List any relevant
tests (Include dates)''; and ``List any relevant laboratory data
(Include dates)'' with corresponding date fields for ``relevant tests''
and ``laboratory data.''
In section B, we are asking whether respondents have a picture of
the product. Also in section B, we are adding the questions ``Does this
report involve cosmetics, dietary supplements, or food?'' and ``Is
therapy still on-going?'' These questions pertain to pharmacovigilance
and the current form does not allow for such specificity. We are also
adding the question, ``Was the product compounded by a pharmacy or an
outsourcing facility?'' Following the question, ``Is the Product
Compounded?'' we are adding a check box for ``Yes'' and a checkbox for
``No.'' We are also adding checkboxes within the field ``Product Type
(check all that apply)'' to correspond with selections for ``Over-the-
Counter, Generic and Biosimilar.'' Finally, we are revising ``Name of
the . . .'' to ``Name(s) of the . . .'' for clarity.
In section C, we are separating ``Other identifying information''
into two fields; hoping this improves reporting. New fields will be
entitled (1) ``Model number'' (2) ``Catalog number'' (3) ``Lot number''
(4) Serial number'' (5) ``UDI Number and (6) ``Expiration Date.''
In section D we are changing the terminology from ``Sex'' to
``Current Gender'' followed by corresponding check boxes next to the
options ``Female'', ``Male'', ``Intersex'', ``Transgender'', ``Prefer
not to disclose''.
In section E, we are revising the question ``If you do NOT want
your identity disclosed to the manufacturer, place an `X' in this
box:'' to read ``If you do NOT want your identity disclosed to the
manufacturer/compounder, place an `X' in this box:''

III. Public Comment

In the Federal Register of March 16, 2018 (83 FR 11756), we
published a 60-day notice requesting public comment on the proposed
collection of information. A number of comments were received and are
discussed in the following paragraphs.
General comments included suggestions that the MedWatch program be
better advertised to physicians and other medical healthcare
professionals as well as patients. Also, that the forms use terminology
more familiar to healthcare providers and consumers. For example, using
`Medication error' or `Medication error/product use error' instead of
`Product use error' to ensure respondents are aware that MedWatch forms
can be used to report medication errors. Other comments suggested
revisions that might improve or otherwise clarify instructions.
Finally, some comments pertained to the advantages of electronic
reporting.
More specific comments included a suggestion to add a question to
section A of Form FDA 3500 related to pregnancy. While we agree that
documenting pregnancy status is important, we do not plan on adding an
additional checkbox for pregnancy at this time. Previously (in 2005),
we proposed adding checkboxes for both ``Product Used During
Pregnancy'' and ``Product Used During Breast Feeding.'' However we
received comments expressing concern that these new data fields
introduced divergence from International Council on Harmonisation
standards and appeared to duplicate information usually provided in the
narrative section and in coded adverse event terms. At the same time,
we ask readers to note that pregnancy status can be captured in field
B7 under ``other relevant history.''
Another comment suggested adding ``Physician Assistant'' to the
drop down ``Occupation'' menu in section G of Form FDA 3500. We
appreciate this

[[Page 46170]]

suggestion and will implement the revision.
We also received comment that some users have experienced ``timing
out'' while completing Form FDA 3500B online and requested that any
time limit for completing online forms be extended. We were not aware
of this issue and will investigate to see whether it relates to the
online functionality of the form. If so, we will make the necessary
adjustments.
While we are especially appreciative of the comments received in
response to our notice, we continue to welcome feedback at all times
regarding ways we might improve the MedWatch Program and the associated
forms. In addition to the revisions discussed previously, on our own
initiative we are now including burden associated with written
submissions under Sec. 329.100(c)(2) (21 CFR 329.100(c)(2)) that
request a temporary waiver from the electronic reporting requirements
associated with postmarket adverse drug events under section 760 of the
FD&C Act. While we expect few such waiver requests, we retain a
placeholder for one respondent annually, and we estimate it takes 1
hour to complete the request.
We therefore estimate the burden for the information collection as
follows.

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA center or 21 CFR section and/or FDA form Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation and Research/
Center for Drug Evaluation and Research:
Form 3500................................. 14,727 1 14,727 0.66 (40 minutes)....................... 9,720
Form 3500A (Sec. Sec. 310.305, 314.80, 599 98 58,702 1.21.................................... 71,029
314.98, 600.80, and 1271.350).
Form 3500A (Sec. 310.305 outsourcing 50 2 100 1.21.................................... 121
facilities).
Center for Devices and Radiological Health:
Form 3500................................. 5,233 1 5,233 0.66 (40 minutes)....................... 3,454
Form 3500A (part 803)..................... 2,277 296 673,992 1.21.................................... 815,530
Center for Food Safety and Applied Nutrition:
Form 3500................................. 1,793 1 1,793 0.66 (40 minutes)....................... 1,183
Form 3500A................................ 1,659 1 1,659 1.21.................................... 2,007
Center for Tobacco Products:
Form 3500................................. 39 1 39 0.66 (40 minutes)....................... 26
All Centers:
Form 3500B................................ 13,750 1 13, 750 0.46 (28 minutes)....................... 6,325
Written requests for temporary waiver under 1 1 1 1....................................... 1
Sec. 329.100(c)(2):
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 909,396
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

While we retain the currently approved estimate for the information
collection, as noted previously we have added burden associated with
written submissions under Sec. 329.100.

Dated: September 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19742 Filed 9-11-18; 8:45 am]
BILLING CODE 4164-01-P

46166 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices

312.32, 312.38, 312.55, and 312.56 have and 812.150 have been approved under comment on the proposed collection of
been approved under OMB control OMB control number 0910–0078. information. No comments were
number 0910–0014; 21 CFR 314.50 has In the Federal Register of May 31, received.
been approved under OMB control 2018 (83 FR 25015), FDA published a We estimate the burden of the
number 0910–0001; and 21 CFR 812.35 60-day notice requesting public information collection as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Section of guidance/reporting activity responses per Total hours
respondents responses per response
respondent

5. Sponsor reporting to FDA on DMC recommenda- 37 1 37 0.50 (30 minutes) .. 18.5
tions related to safety.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Section of guidance/recordkeeping activity records per burden per Total hours
recordkeepers responses
recordkeeper recordkeeping

4.1. and 6.4 SOPs for DMCs ....................................... 37 1 37 8 296
4.4.3.2. DMC meeting records ..................................... 370 1 370 2 740

Total ...................................................................... ........................ ........................ ........................ ................................ 1,036
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
Number of disclosures Total annual Average burden
Section of guidance/disclosure activity Total hours
respondents per disclosures per disclosure
respondent

4.4.1.2. Sponsor notification to the DMC regarding 1 1 1 0.25 (15 minutes) ... 0.25
waivers.
4.4.3.2. DMC reports of meeting minutes to the spon- 370 2 740 1 ............................. 740
sor.

Total ...................................................................... ........................ ........................ ........................ ................................ 740.25
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information ACTION: Notice. FOR FURTHER INFORMATION CONTACT:
collection since our last request for Domini Bean, Office of Operations,
OMB approval, we have made no SUMMARY: The Food and Drug Food and Drug Administration, Three
adjustments to our burden estimate. Administration (FDA) is announcing White Flint North, 10A–12M, 11601
that a proposed collection of Landsdown St., North Bethesda, MD
Dated: September 6, 2018. information has been submitted to the
Leslie Kux,
20852, 301–796–5733, PRAStaff@
Office of Management and Budget fda.hhs.gov.
Associate Commissioner for Policy. (OMB) for review and clearance under
[FR Doc. 2018–19799 Filed 9–11–18; 8:45 am] the Paperwork Reduction Act of 1995. SUPPLEMENTARY INFORMATION: In
BILLING CODE 4164–01–P DATES: Fax written comments on the compliance with 44 U.S.C. 3507, FDA
collection of information by October 12, has submitted the following proposed
2018. collection of information to OMB for
DEPARTMENT OF HEALTH AND ADDRESSES: To ensure that comments on
review and clearance.
HUMAN SERVICES the information collection are received, MedWatch: The FDA Medical Products
OMB recommends that written Reporting Program
Food and Drug Administration comments be faxed to the Office of
Information and Regulatory Affairs, OMB Control Number 0910–0291—
[Docket No. FDA–2014–N–1960]
OMB, Attn: FDA Desk Officer, Fax: 202– Revision
Agency Information Collection 395–7285, or emailed to oira_ This information collection supports
Activities; Submission for Office of submission@omb.eop.gov. All FDA’s MedWatch safety information
daltland on DSKBBV9HB2PROD with NOTICES

Management and Budget Review; comments should be identified with the and adverse event reporting program.
Comment Request; MedWatch: The OMB control number 0910–0291 and Members of the public use FDA’s
Food and Drug Administration Medical title ‘‘MedWatch: The Food and Drug MedWatch system to report adverse
Products Reporting Program Administration Medical Products events, product problems, errors with
Reporting Program.’’ Also include the the use of a human medical product, or
AGENCY: Food and Drug Administration, FDA docket number found in brackets when evidence of therapeutic failure is
HHS. in the heading of this document. suspected or identified in clinical use.

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Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 46167

To ensure the marketing of safe and B. Voluntary Reporting: Form FDA 3500 AboutFDA/ReportsManualsForms/
effective products, it is critical that Voluntary reporting of adverse events Forms/UCM163919.pdf) or reporters
postmarketing adverse outcomes and is completed using Form FDA 3500 and may electronically submit a report via
product problems are reported for all may be used by healthcare professionals the MedWatch Online Voluntary
FDA-regulated human healthcare to submit all reports not mandated by Reporting Form (https://
products, including drugs (prescription Federal law or regulation. Individual www.accessdata.fda.gov/scripts/
and nonprescription), biologics, medical health professionals are not required by medwatch/). Reporting is supported for
devices, dietary supplements, and other law or regulation to submit reports to drugs, non-vaccine biologicals, medical
special nutritional products (e.g. infant the Agency or the manufacturer with the devices, special nutritional products,
formula and medical foods), and exception of Childhood Vaccine Injury cosmetics, and non-prescription (over-
cosmetics. To facilitate reporting on Act of 1986 (42 U.S.C. 300aa–1). Reports the-counter (OTC)) human drug
human medical products (except for vaccines are not submitted via products marketed without an approved
vaccines) during their postapproval and MedWatch or MedWatch forms, but are application. The paper form may also be
marketed lifetimes, we have developed submitted to the Vaccines Adverse used to submit reports about tobacco
three forms (collectively known as the Event Reporting System, which is products and dietary supplements.
MedWatch forms). Form FDA 3500 is jointly administered by FDA and the Electronic reports for tobacco products
intended to be used for voluntary (i.e., Centers for Disease Control and and dietary supplements may be
not mandated by law or regulation) Prevention and approved under OMB submitted to the Agency via an online
reporting by healthcare professionals; control number 0910–0308. submission route called the Safety
Form FDA 3500A is used for mandatory Hospitals are not required by Federal Reporting Portal (https://
reporting (i.e., required by law or law or regulation to submit reports www.safetyreporting.hhs.gov/).
regulation); and Form FDA 3500B is associated with drug products,
biological products, or special C. Mandatory Reporting: Form FDA
written in plain language and is
nutritional products. However, hospitals 3500A
intended to be used for voluntary
reporting (i.e., not mandated by law or and other user facilities are required by 1. Drug and Biological Products
regulation) by consumers (i.e., patients Federal law to report medical device-
and their caregivers). Information related deaths and serious injuries. In sections 505(b) and (j), 503B, and
collected by the forms is used to assess Under Federal law and regulation, 704 (21 U.S.C. 355(b) and (j), 353B, and
and evaluate risks associated with FDA- section 761(b)(1) of the FD&C Act, a 374) of the FD&C Act, Congress has
regulated products, enabling us to take dietary supplement manufacturer, required that important safety
appropriate action to reduce, mitigate, packer, or distributor whose name information relating to all human drug
or eliminate the public’s exposure to the appears on the label of a dietary products be made available to FDA so
risk through regulatory and public supplement marketed in the United that it can take appropriate action to
health interventions. States is required to submit to FDA any protect the public health when
serious adverse event report it receives necessary. Section 702 of the FD&C Act
I. Background regarding use of the dietary supplement (21 U.S.C. 372) authorizes
in the United States. However, FDA investigational powers to FDA for
A. Authorizing Statutes and Codified bears the burden to gather and review
Regulations enforcement of the FD&C Act. These
evidence that a dietary supplement may statutory requirements regarding
The Federal Food, Drug, and Cosmetic be adulterated under section 402 of the mandatory reporting have been codified
Act (FD&C Act) (21 U.S.C. 353b, 355, FD&C Act (21 U.S.C. 342) after that by FDA under parts 310 and 314 (drugs)
360i, 360l, and 393) and the Public product is marketed. Therefore, the and 600 (biological products).
Health Service Act (42 U.S.C. 262) Agency depends on the voluntary Mandatory reporting of adverse
require FDA to collect mandatory reporting by health professionals, and reactions for HCT/Ps has been codified
adverse event reports from regulated especially by consumers, of suspected in § 1271.350.
industry on medical products once they serious adverse events and product
quality problems associated with the 2. OTC Monograph Drug Products and
have been approved for marketing,
use of dietary supplements. All dietary Dietary Supplements
enabling the Agency to monitor the
supplement reports were previously
safety of drugs, biologics, medical Section 760 of the FD&C Act provides
received by the Agency on paper
devices, and dietary supplements. for mandatory safety reporting for non-
versions of Form FDA 3500 (or Form
Postmarket reporting for medical foods, prescription human drug products
FDA 3500B) (by mail or Fax). Currently,
infant formula, cosmetics, and tobacco marketed without an approved
electronic reports may be sent to the
products is done voluntarily. application as described in the Dietary
Agency via an online submission route
Requirements regarding mandatory called the Safety Reporting Portal Supplement and Nonprescription Drug
reporting of adverse events or product (https://www.safetyreporting.hhs.gov/ Consumer Protection Act (Pub. L. 109–
problems are codified at parts 310, 314, approved under OMB control number 462), which became law on December
600, and 803 (21 CFR parts 310, 314, 0910–0645). In that case, Form FDA 22, 2006. The law requires
600, and 803), specifically §§ 310.305, 3500 (or Form FDA 3500B) is not used. manufacturers, packers, and distributors
314.80, 314.98, 600.80, 803.30, 803.50, Form FDA 3500 may be used to report of nonprescription, OTC human drug
803.53, 803.56, and specified in sections to the Agency serious adverse events, products marketed without an approved
daltland on DSKBBV9HB2PROD with NOTICES

503B, 760, and 761 of the FD&C Act (21 product problems, and product use application (OTC monograph drug
U.S.C. 353b, 379aa, and 379aa–1). errors and therapeutic failures. The form products) to submit reports of adverse
Mandatory reporting of adverse is provided in both paper and electronic experiences from domestic sources. The
reactions for human cells, tissues, and formats. Reporters may mail or Fax law also requires reports of serious
cellular- and tissue-based products paper forms to the Agency (a fillable adverse events to be submitted to FDA
(HCT/Ps) is codified at § 1271.350 (21 PDF version of the form is available at by manufacturers of dietary
CFR 1271.350). https://www.fda.gov/downloads/ supplements.

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46168 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices

3. Postmarketing Safety Reports— section 519 of the FD&C Act. The extensive input from consumer
Changes in Format Starting in June 2018 MDUFMA amendment (section 303) advocacy groups and the general public.
Current requirements specify that required FDA to revise the MedWatch Form FDA 3500B may be used to report
postmarketing adverse experience forms to facilitate the reporting of to the Agency adverse events, product
reports must be submitted on paper on information relating to reprocessed problems, and product use errors. The
Form FDA 3500A (or the CIOMS) single-use devices, including the name form is provided in both paper and
(Council for International Organizations of the reprocessor and whether the electronic formats. Reporters may mail
of Medical Sciences) I form for serious, device has been reused. or Fax paper forms to the Agency (a
unexpected adverse experiences from a D. Voluntary Reporting by Consumers: fillable PDF version of the form is
foreign source). For the last several Form FDA 3500B available at https://www.fda.gov/
years the Agency has accepted downloads/AboutFDA/
Form FDA 3500B was developed for ReportsManualsForms/Forms/
electronic submissions in lieu of the voluntary reporting by consumers (i.e.
paper Form FDA 3500A on the UCM349464.pdf) or electronically
patients and their caregivers) to submit submit a report via the MedWatch
condition they are submitted in a reports not mandated by Federal law or
manner that the Agency can process, Online Voluntary Reporting Form
regulation. Individual patients or their (https://www.accessdata.fda.gov/
review, and archive. On June 10, 2014, caregivers are not required by law or
the Agency issued a final rule entitled scripts/medwatch/, approved under
regulation to submit reports to the OMB control number 0910–0645).
‘‘Postmarketing Safety Reports for Agency or the manufacturer.
Human Drug and Biological Products; Reporting is supported for drugs, non-
FDA supports and encourages direct vaccine biologicals, medical devices,
Electronic Submission Requirements’’ reporting to the Agency by consumers
(79 FR 33072) that requires electronic special nutritional products, cosmetics,
and healthcare professionals of and non-prescription OTC human drug
submission of all mandatory suspected serious adverse outcomes and
postmarketing safety reports, including products marketed without an approved
other product problems associated with
individual case safety reports. Entities application. The paper form may also be
human medical products, (https://
with mandatory reporting obligations used to submit reports about tobacco
www.fda.gov/Safety/ReportaProblem/
under parts 310 and 314 (drugs) and 600 products and dietary supplements.
default.htm). FDA has further
(biological products) and specified Electronic reports for tobacco products
encouraged voluntary reporting by
under section 760 of the FD&C Act must and dietary supplements may be
requiring inclusion of the MedWatch
implement this rule within 1 year of the submitted to the Agency via an online
toll-free phone number or the
issuance date (by June 10, 2015). For submission route called the Safety
MedWatch internet address on all
more information see: https:// Reporting Portal (https://
outpatient drug prescriptions dispensed,
www.gpo.gov/fdsys/pkg/FR-2014-06-10/ as mandated by section 17 of the Best www.safetyreporting.hhs.gov/, approved
pdf/2014-13480.pdf. Pharmaceuticals for Children Act (Pub. under OMB control number 0910–0645).

4. Medical Device Products L. 107–109). II. Proposed Modification to Existing
On March 25, 2008, section 906 of the Forms FDA 3500, 3500A, and 3500B
Section 519 of the FD&C Act (21 Food and Drug Administration
U.S.C. 360i) requires manufacturers and Amendments Act of 2007 (Pub. L. 110– A. General Changes
importers of devices intended for 85) amended section 502(n) of the FD&C The proposed modifications to Form
human use to establish and maintain Act (21 U.S.C. 352(n)) and mandated FDA 3500 and Form FDA 3500A reflect
records, make reports, and provide that published direct-to-consumer changes that will bring the form into
information, as the Secretary of Health advertisements for prescription drugs conformity, since the previous OMB
and Human Services may, by regulation, include the following statement printed authorization in 2015, with current
reasonably be required to provide in conspicuous text (this includes regulations, rules, and guidances and
assurance that such devices are not vaccine products): ‘‘You are encouraged fall into three categories: (1) Regulatory
adulterated or misbranded and to to report negative side effects of driven revisions, (2) work
otherwise assure its safety and prescription drugs to the FDA. Visit improvements for the Center, and (3)
effectiveness. The Safe Medical Devices https://www.fda.gov/safety/medwatch, report processing improvements. We
Act of 1990 (Pub. L. 101–629), signed or call 1–800–FDA–1088.’’ also welcome comments about
into law on November 28, 1990, amends Most private vendors of consumer translation of Form FDA 3500B
section 519 of the FD&C Act. The medication information, the drug (consumer) into Spanish and other
amendment requires that user facilities product-specific instructions dispensed languages. Lastly, formatting
such as hospitals, nursing homes, to consumers at outpatient pharmacies, modifications are being proposed to
ambulatory surgical facilities, and remind patients to report ‘‘side effects’’ several fields to enhance the quality,
outpatient treatment facilities report to FDA and provide contact information utility, and clarity of the information.
deaths related to medical devices to to permit reporting via the MedWatch
FDA and to the manufacturer, if known. process. For this reporting FDA has B. Changes Proposed for Form FDA
Serious illnesses and injuries are to be created Form FDA 3500B, a modified 3500
reported to the manufacturer or to FDA version of Form FDA 3500 tailored for In section A, we are revising the
if the manufacturer is not known. These consumers and written in plain heading of A3 to ‘‘Current Gender’’
statutory requirements regarding language (in conformance with the Plain followed by check boxes next to the
mandatory reporting have been codified Writing Act of 2010 (Pub. L. 111–274), following options ‘‘Female’’, ‘‘Male’’,
daltland on DSKBBV9HB2PROD with NOTICES

by FDA under part 803. Part 803 https://www.gpo.gov/fdsys/pkg/PLAW- ‘‘Intersex’’, ‘‘Transgender’’, ‘‘Prefer not
mandates the use of Form FDA 3500A 111publ274/pdf/PLAW- to disclose.’’
for reporting to FDA on medical 111publ274.pdf). In section B, we are revising B1 to
devices. The Medical Device User Fee Form FDA 3500B evolved from ‘‘Type of Report (check all that apply)’’.
and Modernization Act of 2002 several iterations of draft versions, with In section B2, we are removing
(MDUFMA) (Pub. L. 107–250), signed input from human factors experts, from ‘‘(Devices)’’ from the last option. We are
into law October 26, 2002, amended other regulatory agencies, and with also splitting section B6 into two

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Document Created: 2018-09-12 02:06:46
Document Modified: 2018-09-12 02:06:46

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by October 12, 2018.
Contact		Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]
FR Citation		83 FR 46166

83 FR 46166 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 177 (September 12, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration